Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)
NCT ID: NCT00325130
Last Updated: 2015-03-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1042 participants
INTERVENTIONAL
2006-04-30
2007-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
NCT00777257
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
NCT00329901
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
NCT00355121
Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine
NCT00304265
Safety and Immunogenicity Study for Use of Menactra® Versus Adacel® in Subjects 11 to 55 Years of Age in South Korea
NCT01642589
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Concomitant Administration
Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine
Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a
0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
Comparator: Menactra™ (Concomitant)
A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1
Comparator: Adacel™ (Concomitant)
a single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1
Group 2
Non-concomitant administration
Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine
Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a
0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
Comparator: Menactra™ (Non-concomitant)
A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
Comparator: Adacel™
A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine
Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a
0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
Comparator: Menactra™ (Concomitant)
A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1
Comparator: Adacel™ (Concomitant)
a single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1
Comparator: Menactra™ (Non-concomitant)
A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
Comparator: Adacel™
A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must be a virgin with no intention of becoming sexually active during the study period
* Must have been properly vaccinated against diphtheria, tetanus and pertussis
Exclusion Criteria
* Must not have received any prior human papillomavirus (HPV) vaccine or meningococcal vaccine
11 Years
17 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
Explore related publications, articles, or registry entries linked to this study.
Reisinger KS, Block SL, Collins-Ogle M, Marchant C, Catlett M, Radley D, Sings HL, Haupt RM, Garner EI; Protocol 025 Investigators. Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel. Pediatrics. 2010 Jun;125(6):1142-51. doi: 10.1542/peds.2009-2336. Epub 2010 May 3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2005_092
Identifier Type: -
Identifier Source: secondary_id
V501-025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.